ASTELLAS PHARMA
🇯🇵Japan
- Country
- 🇯🇵Japan
- Ownership
- -
- Established
- 2005-01-01
- Employees
- -
- Market Cap
- $22.5B
- Website
- https://www.astellas.com/
CCM Biosciences to Present Breakthrough 4th-Generation EGFR Inhibitors for NSCLC at ASCO 2025
• CCM Biosciences will present data on novel 4th-generation EGFR inhibitors (CCM-205, CCM-245, and CCM-308) that overcome both mutational and non-mutational resistance to 3rd-generation inhibitors in NSCLC at ASCO 2025.
• The company's compounds significantly outperform other investigational 4th-generation inhibitors in various drug resistance models and show efficacy as both monotherapies and in combination with existing treatments.
• CCM Biosciences plans to file an Investigational New Drug (IND) application this year to advance clinical candidates from its EGFR inhibitor program into clinical trials.
KaliVir Advances Novel Oncolytic Immunotherapy VET3-TGI in Phase 1/1b Trial for Advanced Solid Tumors
• KaliVir Immunotherapeutics has successfully completed the first cohort of its STEALTH-001 Phase 1/1b trial evaluating VET3-TGI in patients with advanced solid tumors.
• The Data Safety Committee has reviewed safety data and cleared dosing for the next intratumoral and intravenous cohorts, allowing the trial to progress to higher dose levels.
• VET3-TGI is a novel oncolytic immunotherapy designed to selectively kill tumor cells while delivering an immuno-stimulatory payload of interleukin-12 and a TGFbeta inhibitor.
New Global Review Reveals Comprehensive Landscape of Interstitial Cystitis Clinical Trials in 2025
• A newly released global clinical trials review provides extensive data on Interstitial Cystitis research, tracking trial numbers and enrollment trends across major countries worldwide.
• The report categorizes trials by region, phase, status, and sponsorship, highlighting key pharmaceutical companies including Astellas Pharma, AbbVie, Johnson & Johnson, and Pfizer as prominent sponsors.
• This comprehensive analysis serves as a strategic resource for stakeholders making investment decisions in IC research, offering insights into trial success rates and identifying optimal locations for clinical studies.
Global Thrombocytopenia Clinical Trials Market Sees Significant Growth in 2025
• The global thrombocytopenia clinical trials landscape is expanding rapidly with over 25 pharmaceutical companies developing 25+ treatment therapies, according to recent market analysis.
• Key industry players including GSK, Novartis, Amgen, and Sanofi are leading clinical development efforts, with several promising candidates in late-stage trials showing efficacy in reducing thrombocytopenia events.
• Recent advances include Takeda's TAK-755 demonstrating 60% reduction in thrombocytopenia events compared to standard of care, and HUTCHMED completing enrollment for its pivotal Phase III ESLIM-01 trial of sovleplenib for immune thrombocytopenia.
Boehringer Ingelheim Launches Phase II Trial of First-in-Class Oral Treatment for Geographic Atrophy
• Boehringer Ingelheim has initiated the JADE Phase II clinical study to evaluate BI 1584862, a potential first-in-class oral treatment for geographic atrophy, a severe form of age-related macular degeneration.
• Geographic atrophy affects over 5 million people worldwide with more than 40% considered legally blind, creating a significant unmet need for treatments that can slow disease progression and preserve vision.
• The company is simultaneously advancing a second compound, BI 771716, an antibody fragment designed to penetrate retinal layers, demonstrating Boehringer's dual-pathway approach to addressing this debilitating eye condition.
AviadoBio Completes Second Cohort in Phase 1/2 Trial for Frontotemporal Dementia Gene Therapy
• AviadoBio has completed dosing the second cohort in its ASPIRE-FTD clinical trial evaluating AVB-101, a gene therapy for frontotemporal dementia with GRN mutations, with plans to initiate a third cohort in Q3 2025.
• The company reported no clinically significant safety findings in the first cohort through 52 weeks of follow-up, with no immunosuppression required, marking an important milestone in the development pathway.
• AVB-101 uses a novel delivery approach, administering the gene therapy directly to the thalamus via neurosurgical procedure to bypass the blood-brain barrier and target affected brain regions more precisely.
Chromatin Bioscience and Astellas Partner to Develop Cell-Selective Synthetic Promoters for Precision Gene Expression
• Chromatin Bioscience has entered a collaboration agreement with Astellas Pharma to design cell-selective synthetic promoters using its proprietary chromatinLENS platform.
• The partnership aims to enable highly precise and durable gene expression in specific cell types, addressing Astellas' target profile requirements for advanced therapeutic development.
• This collaboration represents a significant milestone for Chromatin Bioscience, validating its synthetic promoter technology as a key enabler in developing precision-targeted biological systems.
CDMO Market Report: Key Regulatory Approvals and Clinical Advances in March-April 2025
• Multiple CDMOs secured significant contract manufacturing opportunities as regulatory bodies approved new indications for established drugs, particularly in oncology and rare diseases.
• AstraZeneca's portfolio saw substantial growth with expanded approvals for Imfinzi, Tagrisso, and Lynparza, strengthening partnerships with contract manufacturers including Lonza, Dottikon, and Samsung Biologics.
• Contract manufacturers supporting treatments for autoimmune conditions showed strong performance, with Argenx's Vyvgart Hytrulo receiving expanded indications for myasthenia gravis and CIDP.
Cell and Gene Therapy Sector Overcomes Manufacturing and Investment Hurdles Amid 30% Funding Growth
• Despite market challenges, the cell and gene therapy (CGT) sector saw investments reach $15.2 billion in 2024, marking a 30% increase from the previous year, with approximately 3,000 developers and 2,000 clinical trials currently active.
• Manufacturing and distribution remain significant obstacles for CGT advancement, with industry leaders highlighting issues including limited treatment center capacity, single-supplier dependencies for critical materials, and patient cell variability that complicates standardization.
• Experts predict the FDA will approve 10-20 cell and gene therapies in 2025, with automation, robotic systems, and in vivo approaches identified as key technological innovations that could help overcome current sector challenges.
Character Biosciences Secures $93M to Advance Precision Therapies for Age-Related Macular Degeneration
• Character Biosciences has raised $93 million in Series B funding to advance two drug candidates for age-related macular degeneration (AMD) into clinical trials this year.
• The company's lead candidates include CTX114, targeting geographic atrophy, and CTX203, designed to prevent progression in intermediate AMD patients by regulating lipid transport.
• Character's precision medicine approach involves analyzing data from over 6,500 AMD patients to identify genetic subtypes, potentially improving upon current treatments like Syfovre and Izervay.
FDA Accepts Scholar Rock's BLA for Apitegromab in Spinal Muscular Atrophy with Priority Review
• The FDA has accepted Scholar Rock's Biologics License Application for apitegromab with priority review, assigning a PDUFA date of September 22, 2025 for this investigational muscle-targeted treatment for spinal muscular atrophy.
• Apitegromab is being developed as an adjunctive therapy for SMA patients already receiving SMN-targeted treatments, potentially offering significant improvements in motor function through its novel mechanism of action.
• The SMA treatment landscape continues to evolve with recent developments including FDA approval of Evrysdi tablets and Biogen's supplemental New Drug Application for a higher dose regimen of nusinersen.
AstraZeneca Invests $2.5 Billion in Beijing to Establish Sixth Global R&D Center
• AstraZeneca has announced a $2.5 billion investment in Beijing over the next five years to establish its sixth global strategic R&D center, despite ongoing investigations into alleged illegal activities in China.
• The new R&D hub will focus on early-stage research and clinical development enabled by AI and data science, with plans to expand the Beijing workforce from 600 to 1,700 employees.
• As part of the investment, AstraZeneca is forming strategic partnerships with Beijing Cancer Hospital and three Chinese biotech companies—Harbour BioMed, Syneron Bio, and BioKangtai—including its first vaccine manufacturing facility in China.
Roche Expands Molecular Glue Portfolio with $2 Billion Monte Rosa Partnership
• Roche has signed a $2 billion partnership with Monte Rosa Therapeutics, including a $50 million upfront payment, to develop molecular glue therapies targeting previously "undruggable" proteins in cancer and neurological diseases.
• This marks Roche's second major molecular glue deal in a month, following a similar $2 billion alliance with Orionis Biosciences, demonstrating the company's strategic push to establish leadership in this emerging therapeutic category.
• Monte Rosa will lead discovery and preclinical activities using its QuEEN platform, with Roche taking over late-stage development of candidates that can potentially address the 80% of human proteins currently inaccessible to traditional drug development approaches.
Lupin Launches Generic Rivaroxaban in US Market Following FDA Approval
• Lupin has launched Rivaroxaban Tablets USP, 2.5 mg in the US market after receiving final approval from the FDA for its Abbreviated New Drug Application.
• The generic equivalent of Janssen's Xarelto® targets patients with coronary artery disease and peripheral artery disease, with estimated annual US sales of $446 million.
• This strategic launch strengthens Lupin's position in the high-value anticoagulant market, following the company's strong Q3 performance with a 38.8% increase in profit.
Astellas and Yaskawa Electric Form $30M Joint Venture to Revolutionize Cell Therapy Manufacturing
• Astellas Pharma and Yaskawa Electric have established a strategic joint venture worth $30 million, combining cell therapy expertise with advanced robotics to automate manufacturing processes.
• The partnership will leverage Yaskawa's dual-arm Maholo robot technology to enhance precision and reproducibility in cell therapy production, addressing key industry challenges.
• Set to launch in September 2025, the venture aims to develop GMP-compliant manufacturing platforms and provide access to startups and academic institutions for innovation advancement.
FDA Updates Testosterone Product Labels Following TRAVERSE Trial Safety Data
• The FDA has mandated new labeling changes for testosterone products based on the TRAVERSE trial, which demonstrated cardiovascular safety in high-risk men with hypogonadism.
• Multiple ambulatory blood pressure monitoring studies revealed consistent increases in blood pressure across all testosterone product classes, prompting new warning requirements.
• The FDA is removing boxed warnings about cardiac risks while retaining limitations for age-related hypogonadism use, based on comprehensive safety evaluations.
Zervimesine Shows Promise in Geographic Atrophy Trial, Building on Success in Multiple CNS Disorders
• Cognition Therapeutics' Phase 2 MAGNIFY trial of zervimesine demonstrates slower lesion growth in geographic atrophy patients compared to placebo after 6 months of treatment.
• The drug previously showed significant benefits in dementia with Lewy bodies trials, with patients showing 86% improvement in neuropsychiatric symptoms and 62% better motor function versus placebo.
• Zervimesine also demonstrated strong results in Alzheimer's disease trials, achieving a 95% reduction in cognitive decline in a biomarker-defined subgroup compared to placebo.
PADCEV-KEYTRUDA Combination Shows Sustained Survival Benefit in Advanced Urothelial Cancer Trial
• Phase 3 EV-302 trial demonstrates PADCEV plus KEYTRUDA reduces mortality risk by 49% compared to chemotherapy in advanced urothelial cancer patients, with median overall survival of 33.8 months versus 15.9 months.
• The combination therapy showed significant progression-free survival benefit of 12.5 months compared to 6.3 months with chemotherapy, representing a 52% reduction in disease progression risk.
• Extended 12-month follow-up data confirms sustained efficacy across all patient subgroups, including both cisplatin eligible and ineligible patients, with no new safety concerns identified.
Clearside's CLS-AX Phase 2b Trial Data Shows Promise in Treatment-Naïve AMD Patients
• New subgroup analyses from Clearside Biomedical's ODYSSEY Phase 2b trial provide strategic insights for upcoming Phase 3 program in neovascular age-related macular degeneration.
• Data presented at the Angiogenesis 2025 meeting supports focusing on treatment-naïve patients and implementing specific visual acuity criteria for future trials.
• The 36-week ODYSSEY trial employed a robust design, being randomized, double-masked, and active-controlled across multiple centers.
FDA Approves Roche's Susvimo for Diabetic Macular Edema, Offering Fewer Injections
• The FDA has approved Roche's Susvimo (ranibizumab injection) for treating diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes.
• Susvimo is the first FDA-approved treatment for DME that requires fewer injections than standard eye injections, helping to maintain vision for affected individuals.
• The approval was based on the Phase 3 Pagoda study, which demonstrated non-inferior vision improvements with Susvimo refilled every six months compared to monthly ranibizumab injections.
• Susvimo, a refillable eye implant, delivers a customized formulation of ranibizumab continuously, offering a convenient alternative to routine eye injections for DME patients.
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